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6.
The drug delivery device ‘system’ Drug Delivery Primary Device Container Drug Patient• The primary container and delivery device are the ‘drug to patient interface’• This is the key interface in the system, as there is limited control over the patient / user actions• The device choice (and design) is the opportunity to get it ‘right’ for the patient and reduce the occurrence of use-related errors

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Broad Commercial & Technical Criteria Implementable? Implementable? Can technical, Can technical, industrialisation and industrialisation and regulatory issues be regulatory issues be overcome? overcome? Adaptable? Adaptable? Available? Available? Can the device be adapted Can the device be adaptedIs ititthe right device at the Is the right device at the to suit delivery to suit delivery right price? right price? requirements? requirements? Protectable? Protectable? Acceptable? Acceptable? Can the device provide Can the device provide Will the device be Will the device be sustained competitive sustained competitive acceptable? (by patients, acceptable? (by patients, advantage? advantage? HCP’s, payers etc.) HCP’s, payers etc.) Simpson.I – Team Consulting

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Consideration during selection1. Medical Condition (Patient)• What do you know about the patient condition that might influence acceptance?• What is the dexterity and cognitive ability of the target population?• What is the dose frequency? Single or multi dose / Fixed or variable dose?• What is the period of treatment i.e. chronic disease vs. short term treatment?• Who will administer? Self (Home) or HCP (Hospital) administration?• Are there specific safety requirements that need to be considered e.g. timer lockouts?2. Treatment (Drug)• Will the device cope with the drug/treatment characteristics?• What is the dose volume? — An auto-injector is typically <1ml• What is the drug viscosity?• Is reconstitution required?• Is injection time important for the therapy?• What is the delivery depth?

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Consideration during selection3. Primary Packaging•Which type of primary container will be used? Is it defined?•Who will undertake filling and final device assembly?•What are the challenges associated with the primary pack thatmight influence device choice? E.g. for a PFS — Removal force of needle shield — Dimensional tolerances — Break loose force and glide force variance — Accommodation of PFS during auto-injection — Use of a rigid needle shield or soft needle shield•Does stability data exists for a primary container?4. Marketing• Will the delivery characteristics offer competitive advantage? How adventurous do you need to be? — What is expected the patient experience? — What will be the perceived value of the device - ‘Me too’ or unique design?• How will the treatment be offered? — Multiple devices to meet differing user requirements — Device platform used for other treatments.

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Consideration during selection5. Commercial and Operational• What type of commercial agreement is preferred ? — Who owns what IP? What is being for license? — Who owns the component tools? — Who will undertake final fill and assembly?• What are the timelines for clinical trials and product launch?• What is the launch and scale up strategy?• What is the cost per device / cost per dose?6. Human Factors Engineering (HFE)• Will the device be safe and effective to use by the intended user FDA guidance groups with a realistic level of training? ISO/IEC 62366 (incl. ANSI/AAMI HE74) ANSI/AAMI HE75:2009•FDA guidance on applying HFE in medical device design should influencethe process of device selection— Regulatory submissions must show a sensible programme of HFE in identifying and mitigating risk associated with use error• Separate exploratory and summative studies will be required for each medication and associated user group(s).

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Consideration during selection7. Technical status•What stage of development is the technology? — Prototype? — Proven for other drug products and partners?•What evidence of development analysis and testing Is available?•What is known of the delivery window characterisation – viscosities,delivery time, volume etc.•Evidence of formative HF studies / experience with intended patientgroups?8. Regulatory•For biosimilars… how close does delivery method need to be to thereference product?•How will the device be regulated? A medical device or a combinationproduct?•The route for submission will affect the level of complexity and risk

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Selection – Develop or License?Develop Benefits •Secure IP to maintain competitive advantage1.Create own device (‘ground up’ development) •No ‘fuss’ tailored development to meet yourbased on new or expired IP own specific requirements •Freedom to select the right manufacturing process capabilitiesLicense Benefits2.Develop a device with licensed IP for a specific •More predictable / manageable technical risk,combination of technical feature(s) from a device cost and timescalesupplier •Reduced time to market - partially developed already3.Licence and customise an existing device core •Known (sometimes proven) technology withtechnology to meet particular user / delivery access to manufacturing capabilityrequirements •Early development costs spread across other non-competing sectors4.Licence use of an existing device with no •Allows pharma/biotech to retain focus on corechanges to device other than branding / colour competence •Reduced risk of IP infringement

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The ‘IDEAL’ device for Biologics... Creating a positive user An injector people are WILLING experience to use Co o ry mm lat gu erc Re Appealing ial An injector people CAN use An injector that can be MANUFACTURED to FUNCTION as intendedSafe and intuitive or ‘learnable’ Ensuring robustness and in the hands of the user Technical reliability

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Essential Attributes - Functionality• Invite input from all stakeholders – the functional specification represents all needs and expectations – there should be no surprises• Even for an ‘off the shelf’ injector, understand how and why the device design works and where its limits are — Stress test functional samples - in labs and in user’s hands. Face up to likely realities as early as possible — Model, simulate, test and iterate mathematical and physical models — Expect convergence within 10% after 3 iterative loops between the empirical and theoretical — For multi-feature, multi function components – identify critical features/dimensions based on in-depth understanding of the design • Beware - Simulation and functional prototypes provide guidance only — Production versions represent reality — Manufacturability and usability must be built in from project start

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Essential Attributes - Manufacturability• Begin dialogue early – involve a manufacturing partner at design layout level and must be shared by ALL• A sound tolerance allocation methodology enables predictable production — it must reflect the manufacturing processes involved and their capabilities — it must support the high levels of functionality and performance required — dialogue between designer and manufacturer should prevent misunderstandings• Consider high volume component assembly and feeding constraints early– Top-tip; If you can assemble it automatically you can do it manually but this seldom applies vice-versa!

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Conclusions• Delivery of biologics represent a significant and growing demand for safe, effective, patient centred injection devices• Expectations and challenges for delivery performance is rapidly evolving• Suppliers are responding with a vast choice of novel and sophisticated technologies• A rigorous selection process can help avoid downstream headaches and significantly enhance the chance of market success — Consider the device early in the process... even during development of the drug.